COVID-19 Antibody and Reinfection Study

Kaiser Permanente

Status: Completed

Conditions: COVID-19 Testing

Study type: Observational

Funder types: Other

Identifiers

NCT05365750

1589316-19

Details and patient eligibility

About

The goal of this study is to establish a cohort of Kaiser Permanente Colorado (KPCO) members who have and have not had COVID-19 infection for serial antibody testing and PCR testing to:

1. Quantify antibody titers among participants over 9 months.
2. Determine the rates of asymptomatic, mild, and severe recurrent infection among participants with prior COVID-19.
3. Examine association between antibody titer levels and risk of recurrent infection using a case control analysis nested in the cohort.

Full description

In this study, the Kaiser Permanente Colorado (KPCO) Institute for Health Research (IHR) will evaluate SARS-CoV-2 IgG antibody titers over time among individuals with evidence of prior infection, and correlate antibody titers with risk of recurrent infection. The investigators will identify KPCO members who have and have not had prior infection, enroll them into a cohort study, conduct serial surveys for new COVID-19 symptoms, and facilitate serial viral and antibody testing.

All laboratory testing procedures and clinical management of participants will be conducted by KPCO operations. The research team will identify participants, obtain consent, administer surveys to assess COVID-19 symptoms, and direct patients to the appropriate testing. Health outcomes on cohort participants will be tracked with survey data on symptoms, clinical and utilization data from the KPCO electronic health record (e.g., hospitalization), and laboratory data (e.g., viral test results).

This research-operations partnership strategy will generate data to better understand the implications of positive antibody titers to this novel pathogen.

Enrollment: 4,235 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria are Kaiser Permanente Colorado health plan members, with a valid email address or phone number in the electronic health record and not on the Do Not Call List for research.

Trial design

4,235 participants in 2 patient groups

Case

Description:

Case patients were drawn from a random sample of individuals who were enrolled in KPCO's health plan had suspected or confirmed SARS-CoV-2 infection and a random stratified sample of the general KPCO membership with similar age, gender, race/ethnicity and co-morbidities as case group. Within the cohort, case patients had a SARS-CoV-reinfection, defined as a positive SARS-CoV-2 RNA test ≥ 90 days after the first positive RNA test.

Control

Description:

Control patients were drawn from a random sample of individuals who were enrolled in KPCO's health plan had suspected or confirmed SARS-CoV-2 infection and a random stratified sample of the general KPCO membership with similar age, gender, race/ethnicity and co-morbidities as case group. Within the cohort, control patients had no evidence of a SARS-CoV-reinfection during the period of interest.